FDA warns beverage firms on health claims

In another sign that the regulatory environment has changed, the U.S. Food and Drug Administration recently sent letters to 16 firms – including five RTD beverage companies – citing ingredient and health claim violations.

The agency’s letter to POM Wonderful said POMs expansive health claims – including boasts that it may help with blood pressure, prostate cancer and erectile function – elevate POM to the level of unapproved drug rather than a food product.

The agency chastised the brand, a leader in the trend toward more-prevalent antioxidant claims, for using its web site to bring attention to scientific studies and customer testimonials that suggest the product can improve consumers’ health.

POM’s label also improperly lists its nutrition content, the FDA said, by omitting the name of its antioxidant. The label also boasts a high level of “phytochemicals,” which are not eligible for a nutrition panel call-out because the FDA has not established a recommended daily intake for the substance.

“All statements made in connection with POM products are true and supported by unprecedented scientific research,” POM Wonderful said in a written statement. “We are currently reviewing the FDA’s concerns and, as strong advocates of honest labeling and fair advertising, we are looking forward to working with the agency to resolve this matter. Once the FDA reviews and better understands the substantial science, we are confident that the agency will agree with our position.”

But regulators have displayed a pattern of increasing scrutiny toward food and beverage products. In November, the FDA sent letters to firms marketing alcohol/energy drink hybrids demanding that they prove that the drinks are safe, and, in May, the agency announced that Cheerios’ claim to boost heart health broke federal rules. Additionally, caloric beverages have become targets for proposed state and federal taxes, and this round of FDA letters included a complaint against Salada tea bag marketer Redco Foods, Inc.

The agency slapped Nestle’s Juicy Juice with a warning in December for violating regulations specific to children’s foods and beverages. Its “no sugar added” claim is not authorized for products intended for children under the age of 2, the FDA said. First Juice received a similar warning this month, but the FDA went further with Nestle, calling the labels on the offending products “misleading.” Juicy Juice’s Orange Tangerine and Grape products both claim, in bold letters, to be 100 percent juice, but clarify in smaller letters that they are not 100 percent Orange Tangerine or Grape juice.

The FDA also sent a letter to Innovative Beverage Group, Inc., warning that the melatonin in drank is not approved for food and beverage products. Brand founder Peter Bianchi said the complaint amounts to little more than paperwork. The FDA based its warning on outdated information, Bianchi said. drank is classified as a dietary supplement, he said, much like Red Bull, Rockstar or Monster, but initially reached the market in packaging that labeled it as a beverage, an error that has been resolved for more than six months.